MAUDE Adverse Event Report: ATRICURE, INC. EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX

Model Number CDK-1413

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Perforation of Esophagus (2399)

Event Type  Death  

Manufacturer Narrative

(b)(4).The device was not returned to atricure for evaluation as there was no complaint of a device defect or malfunction.

Event Description

Through a conversation on (b)(6) 2017, a company representative came to know of a patient who on (b)(6) 2017, had a hybrid ablation surgical procedure simultaneous with ep catheter ablation.The surgical ablation was done first with the surgeon getting subxiphoid access and the ep doctor did the ep catheter ablation to follow via access through the groin using the biosense contact force ablation catheter with the patient being heparinized with an unknown amount.Approximately 2 weeks post procedure, the patient presented at a different facility with chest pain where apparently, air was found in the pericardium.The patient was then transferred to the facility where the original procedure had taken place and a contrast study was done.An atrioesophageal fistula was determined and the patient went directly for surgery.Once in surgery, they could not find anything to repair.The patient died a few days later.The exact date of the patient expiring is not known and an autopsy was not performed.

• Brand Name: EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX
• Type of Device: EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: anupam bedi
• MDR Report Key: 7094845
• MDR Text Key: 94061304
• Report Number: 3011706110-2017-00102
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: CDK-1413
• Device Catalogue Number: CDK-1413
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CSK-6130, CSK-2000, BIOSENSE CONTACT FORCE CATHETE
• Patient Outcome(s): Death